Recall Z-0563-2020— Wright Medical Technology, Inc.

Name: FDA recall Z-0563-2020
Creator: U.S. Food and Drug Administration
Published: 2016-11-08

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2016-11-08, terminated 2020-11-03. It names one FDA 510(k) clearance: K102429. Product: ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538. Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-08
Terminated: 2020-11-03
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K102429 — ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREWWrightmedicaltechnologyinc·cleared 2010-11-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

Reason for recall

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Data sourced from openFDA. This site is unofficial and independent of the FDA.